12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress
- Conditions
- DepressionSexual Dysfunctions, Psychological
- Interventions
- Registration Number
- NCT01040208
- Lead Sponsor
- Sprout Pharmaceuticals, Inc
- Brief Summary
The current trial will explore the safety of flibanserin in combination with Selective Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a representative population of women with depressive and possible concurrent anxiety symptomatology.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 111
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description flibanserin 100 mg qhs flibanserin 100 mg qhs Patient to receive 2 flibanserin tablets of 50 mg qhs flibanserin 50 mg to 100 mg qhs flibanserin 50 mg to 100 mg qhs Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs placebo 2 tablets qhs placebo 2 tablets qhs Patient to receive 2 placebo tablets of 50 mg qhs
- Primary Outcome Measures
Name Time Method The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period. 17 weeks
- Secondary Outcome Measures
Name Time Method The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12) 12 weeks The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12) 12 weeks
Trial Locations
- Locations (39)
Western Affiliated Research Institute
🇺🇸Denver, Colorado, United States
Albuquerque Neuroscience
🇺🇸Albuquerque, New Mexico, United States
Clinco
🇺🇸Terre Haute, Indiana, United States
Future Search Trials
🇺🇸Austin, Texas, United States
Alliance Research Group
🇺🇸Richmond, Virginia, United States
Millennium Psychiatric Associates
🇺🇸Creve Coeur, Missouri, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Schuster Medical Research
🇺🇸Sherman Oaks, California, United States
Capstone Clinical Research
🇺🇸Livertyville, Illinois, United States
ActivMed Practices and Research
🇺🇸Haverhill, Massachusetts, United States
Medical and Behavioral Health Research
🇺🇸New York, New York, United States
Bioscience Research
🇺🇸Mount Kisco, New York, United States
Mary Ann Knesevich
🇺🇸Irving, Texas, United States
Mood & Anxiety Research
🇺🇸Fresno, California, United States
Gulf Coast Clinical Research
🇺🇸Fort Myers, Florida, United States
Kolin Research Group
🇺🇸Winter Park, Florida, United States
Comprehensive Neuroscience
🇺🇸Atlanta, Georgia, United States
Psychiatric Medicine Associates
🇺🇸Skokie, Illinois, United States
Sheppard Pratt Hospital
🇺🇸Baltimore, Maryland, United States
Atlanta Institute of Medicine & Research
🇺🇸Atlanta, Georgia, United States
CRI Worldwide
🇺🇸Philadelphia, Pennsylvania, United States
San Antonio Psychiatric Research Center
🇺🇸San Antonio, Texas, United States
Clinical Trials Technology
🇺🇸Prairie Village, Kansas, United States
Clinical Innovations
🇺🇸Riverside, California, United States
Synergy Clinical Research Center
🇺🇸National City, California, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Ali Kashfi
🇺🇸Altamonte Springs, Florida, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Chicago Research Center
🇺🇸Chicago, Illinois, United States
Social Psychiatry Research Institute
🇺🇸Brooklyn, New York, United States
Neurobehavioral Research
🇺🇸Cedarhurst, New York, United States
MIdwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Clinical Neuroscience Solutions
🇺🇸Memphis, Tennessee, United States
Radiant Research
🇺🇸Denver, Colorado, United States